FDA OKs use of Medtronic's CoreValve TAVR on end-stage renal disease patients

Medtronic's CoreValve Evolut R TAVR--Courtesy of Medtronic

Medtronic ($MDT) announced an improved FDA indication for its CoreValve TAVR franchise, saying the agency has revised the label for the device to make it eligible for use on patients with end-stage renal disease and those with low-flow, low-grade aortic stenosis.

The moves give the company bragging rights over rival Edwards Lifesciences, whose Sapien line of TAVRs does not possess the favorable labeling, according to a company spokeswoman.

Previously, Medtronic's instructions for use contained precautions against treating patients with those conditions. A Medtronic spokeswoman said over email that the decision was based on the CoreValve U.S. expanded use study of high- and very-high-risk subject who need an aortic valve replacement.

Patients with low-gradient aortic stenosis had a one-year mortality rate of 23.1% and major stroke rate of 4.9%. Those with end-stage renal disease had a one-year mortality rate of 32.7% and 1% major stroke rate, the company said at the Transcatheter Cardiovascular Therapeutics (TCT) conference in October.

Medtronic earned approval to modify the labeling in November, according to the FDA's PMA database. And the indication change covers the company's current generation CoreValve Evolut R and the first-generation CoreValve, the database shows.

Medtronic last March announced an indication expansion to include so-called "valve-in-valve" procedures. In other words, the FDA granted the company permission to market the device for the replacement of previously installed, failed artificial aortic valves. Valve-in-valve patients had an all-cause mortality rate or 13.4% and major stroke rate of 3.1%, Medtronic said in October.

Rival Edwards ($EW) gained permission to use its Sapien XT on valve-in-valve procedures in October, but not its current-generation Sapien 3. Medtronic has said its valve-in-valve indication applies to its current generation Evolut R, putting it at a slight advantage.

Medtronic welcomes indication enhancements that encourage use of its TAVR on patients at the high end of the risk spectrum, but knows that the financial gains and patient population expansion is peanuts compared to that which would occur from permission to use the CoreValve on "intermediate-risk" patients.

After all, TAVRs are already permitted for use on almost all high-risk patients, or those who are too frail to withstand the rigors of open heart surgery. The FDA is removing restrictions removing on that set of patients, as today's announcement shows.

But an expanded indication to include intermediate-risk patients would enable marketing of TAVRs to a whole new group of younger patients who are healthy enough to survive open heart surgery.

Edwards earned FDA approval of its Sapien ahead of Medtronic's CoreValve, putting it on track to become the first company to earn that coveted intermediate-risk indication, a milestone that could occur as early as late this year, pending additional study results.